USA: Aquaflor now permitted for all freshwater-reared finfish

Aquaflor (florfenicol) has received new label indications in the United States permitting its use in all freshwater-reared finfish.

According to Palma Jordan, global marketing director for aquatic animal health products at MSD Animal Health (known as Merck Animal Health in United States and Canada), “the new claims for Aquaflor in the United States reflect the company’s ongoing global effort to develop products for aquaculture.” The major changes to the Aquaflor label in the United States include:

can now be used in tilapia, striped bass, catfish, trout, and all other freshwater-reared finfish at 10 to 15 mg/kg bodyweight per day for the control of mortality due to columnaris disease associated with Flavobacterium columnare.

is approved for use in all freshwater-reared warmwater finfish at 15 mg/kg for the control of mortality due to streptococcal septicemia associated with Streptococcus iniae, an organism known to cause significant economic losses in farm-raised tilapia and some other species.

has a single withdrawal period of 15 days for all finfish species treated at dose rates of 10 to 15 mg/kg.

The new claims approved by the US Food and Drug Administration give Aquaflor the broadest range of approved fish species and indications of any aquatic animal health antibiotic used in the United States. The new indications are also exclusive to the Aquaflor brand of florfenicol.

MSD Animal Health emphasized that the new withdrawal time was established to facilitate compliance across all species and dose rates without any change in the high safety profile. Aquaflor was developed specifically for aquaculture use; its active ingredient – florfenicol - is not used in human medicine.

As before, Aquaflor is also approved in the United States for the control of mortality due to enteric septicemia (ESC) associated with Edwardsiella ictaluri in catfish, as well as for the control of mortality due to furunculosis associated with Aeromonas salmonicida and coldwater disease associated with Flavobacterium psychrophilum in freshwater-reared salmonids.

Aquaflor, which can be top-coated or incorporated in both floating and sinking feeds, has been shown to be highly stable following high-temperature extrusion at feed mills. It is also highly palatable, which helps to optimize antibiotic intake. Aquaflor medicated feed should be administered as the sole ration for 10 consecutive days. It is not approved for use in breeding stock or for use in recirculating aquaculture systems.